Evaluation of Zinc Oxide Eugenol and Iodoform-Calcium Hydroxide as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files

NCT07395401 | Recruiting DMC

• 1 other identifier: U MSA Nanis
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as root canal filling materials in primary molars prepared using either rotary or manual instrumentation techniques. Forty-four teeth from children aged 5-8 years indicated for pulpectomy will be randomly allocated into four equal groups based on the combination of instrumentation method and filling material. Clinical parameters-pain, mobility, and sensitivity-will be assessed using standardized scales, while radiographic outcomes, including root resorption and bone density, will be evaluated using Cone Beam Computed Tomography (CBCT) at baseline, 6 months, and 12 months. The study seeks to determine which obturation material and canal preparation technique yield superior healing, adaptation, and resorption compatible with the physiological process of primary tooth exfoliation. Findings are expected to inform evidence-based selection of endodontic materials and instrumentation methods in pediatric dentistry.

Conditions

Carious Primary Molars Indicated for Pulpectomy

Keywords

Iodoform-Calcium Hydroxide; Metapex; Zinc Oxide Eugenol; Manual Instrumentation Method; Rotary Instrumentation Method; pulpectomy; primary molars; radiographic assessment; clinical assessment

Outcome Measures

Primary Outcomes (1)

• Radiographic Success

  Radiographic success will be assessed by evaluating root resorption in treated primary molars. Cone Beam Computed Tomography (CBCT) will be used to measure the degree of root resorption in millimeters, allowing comparison between zinc oxide eugenol (ZOE) and iodoform-calcium hydroxide (Metapex) obturation materials in canals prepared by rotary and manual instrumentation techniques.

  Baseline, 6 months, and 12 months

Secondary Outcomes (3)

• Postoperative Pain

  Baseline, 6 months, and 12 months

• Tooth Mobility

  Baseline, 6 months, and 12 months

• Tooth Sensitivity

  Baseline, 6 months, and 12 months

Study Arms (4)

Arm A: Manual Instrumentation and Metapex

EXPERIMENTAL

Primary molar teeth will undergo pulpectomy using Manual instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).

Procedure: Manual Instrumentation; Drug: Iodoform-Calcium Hydroxide (Metapex)

Arm B: Rotary Instrumentation and Metapex

EXPERIMENTAL

Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).

Drug: Iodoform-Calcium Hydroxide (Metapex); Procedure: Rotary Instrumentation

Arm C: Manual Instrumentation and ZOE

ACTIVE COMPARATOR

Primary molar teeth will undergo pulpectomy using manual instrumentation followed by obturation with zinc oxide eugenol (ZOE).

Procedure: Manual Instrumentation; Drug: Zinc Oxide Eugenol (ZOE)

Arm D: Rotary Instrumentation and ZOE

ACTIVE COMPARATOR

Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with zinc oxide eugenol (ZOE).

Procedure: Rotary Instrumentation; Drug: Zinc Oxide Eugenol (ZOE)

Interventions

Manual Instrumentation PROCEDURE

Root canal preparation of primary molars will be performed using manual stainless-steel hand files with conventional step-back technique for cleaning and shaping of the root canals.

Arm A: Manual Instrumentation and Metapex; Arm C: Manual Instrumentation and ZOE

Iodoform-Calcium Hydroxide (Metapex) DRUG

Metapex (iodoform-calcium hydroxide paste) will be used as the obturating material for filling the prepared root canals of primary molars following pulpectomy.

Arm A: Manual Instrumentation and Metapex; Arm B: Rotary Instrumentation and Metapex

Rotary Instrumentation PROCEDURE

Root canal preparation of primary molars will be performed using nickel-titanium rotary instruments according to the manufacturer's instructions to achieve effective cleaning and shaping of the root canals.

Arm B: Rotary Instrumentation and Metapex; Arm D: Rotary Instrumentation and ZOE

Zinc Oxide Eugenol (ZOE) DRUG

Zinc oxide eugenol paste will be used as the obturating material for filling the prepared root canals of primary molars following pulpectomy.

Arm C: Manual Instrumentation and ZOE; Arm D: Rotary Instrumentation and ZOE

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy cooperative children indicated for partial pulpectomy.
• Restorable primary molars.
• No mobility, or external pathological root resorption.

You may not qualify if:

• Uncooperative children.
• Children with systemic medical illness.
• More than 2/3 of root resorbed.

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

Faculty of Dentistry, MSA University

Giza, Giza Governorate, 12611, Egypt

RECRUITING

MeSH Terms

Interventions

Metapex; Zinc Oxide-Eugenol Cement

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Nanis Nasser, bachelor degree of dentistry

CONTACT

+201152791000; nanis.nasser1@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teacher assistant at pediatric dentistry department

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: February 15, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 15, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)